Bhargava Phytolab Private Limited
Form 483 issued July 26, 2024 · Bhiwadi, India
- Inspection
- Jul 22 – Jul 26, 2024
- Investigators
- Andrew Le· Khoa Nathan V. Tran
- Observations
- 9
- Pages
- 6
- FEI number
- 3012809762
In short: On July 26, 2024, FDA issued a Form 483 with 9 observations to Bhargava Phytolab Private Limited in Bhiwadi, Rajasthan (FEI 3012809762) after an inspection that ran Jul 22 – Jul 26, 2024. The investigators were Andrew Le and Khoa Nathan V. Tran. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
Drug product component testing is deficient in that at least one specific test to verify the…
- 03
Buildings used in the manufacturing and holding of a drug product are not maintained in a…
- 04
EIPLOYEE(S) SIGNATURE Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmBhargava Phytolab Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bhargava Phytolab Private Limited?
FDA listed 9 observations on this Form 483, mostly about quality system, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Bhargava Phytolab Private Limited?
Andrew Le and Khoa Nathan V. Tran are named on this Form 483, for the inspection of Jul 22 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Bhargava Phytolab Private Limited inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Bhargava Phytolab Private Limited?
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